FDA 510(k)

AI-Rad Companion Brain MR

K-Number: K253057 · 2026-01-22

Decision Date2026-01-22

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion Brain MR is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2026-01-22 under approval number K253057. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-Rad Companion Brain MR?

AI-Rad Companion Brain MR is a medical device that received FDA 510(k) clearance on 2026-01-22. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K253057.

When was AI-Rad Companion Brain MR approved by the FDA?

AI-Rad Companion Brain MR received FDA 510(k) clearance on 2026-01-22, under approval number K253057.

What company makes AI-Rad Companion Brain MR?

AI-Rad Companion Brain MR is manufactured by Siemens Healthcare GmbH.

What is the FDA product code for AI-Rad Companion Brain MR?

The FDA product code for AI-Rad Companion Brain MR is QIH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.